JP2015534898A - Osteotome for autologous transplantation - Google Patents

Abstract

The grooved osteotome is rotated in one direction to enlarge the osteotomy site by grinding, and when rotated in the opposite direction, the osteotomy site is enlarged by cutting / drilling. The conically tapered body has a tip including a cutting edge. The cutting edge is set to grind the bone when rotated in the grinding direction and to cut the bone when rotated in the cutting / drilling direction. Spiral grooves and lands placed between them are placed around the body. Each groove has a working end that grinds the bone when rotated in the grinding direction and cuts the bone when rotated in the cutting / drilling direction. The cutting edge and land generate opposite axial reaction forces that enhance surgical control. The osteotome self-implants the bone by reattaching the crushed particles along the entire depth of the osteotomy site, in particular at the bottom, using a method of pressing. [Selection] Figure 11

Description

(Cross-reference of related applications)
This application claims the priority of US Provisional Application No. 61 / 727,849 filed on November 19, 2012, and in the United States, this application was filed on March 23, 2011. September 10, 2012, which is a continuation-in-part of US Application No. 13 / 427,391, filed March 22, 2012, claiming priority from US Provisional Application No. 61 / 466,579. This is a continuation-in-part of U.S. Application No. 13 / 608,307, filed on the same day, the entire disclosure of which is incorporated by reference.

  The field of invention. The present invention relates generally to a tool for preparing a hole for receiving an implant or a fixture, and more particularly to expanding an osteotomy site or an implant or other fixation tool. The present invention relates to a rotating osteotome and a method implemented thereby for enlarging pores in a spongy material for receiving.

  Description of related technology. An implant is a medical device that is manufactured to replace a missing biological structure, to assist a damaged biological structure, or to strengthen an existing biological structure. A bone implant is a type of implant that is implanted in a patient's bone. Bone implants, to name just a few, are jaw bone dental implants to replace missing or damaged teeth, joint implants to replace damaged joints such as the hips and knees, and repair fractures It can be seen throughout the human skeletal system, including reinforced implants that are attached to correct other defects. In many cases, implant placement requires pretreatment of the bone using either a manual osteotome or a precision drill with a highly adjusted speed to prevent bone burnout or compression necrosis. Is done. After a variable period of time allowing the bone to grow on the surface of the implant (or in some cases, a fixed part of the implant), sufficient healing allows the patient to begin rehabilitation therapy or normal use Or perhaps will allow the placement of a restoration or other attachment mechanism.

  In the example of a dental implant, a hole preparation or osteotomy is required to receive a bone implant. According to the latest technology, in the edentulous (toothless) jaw position that needs to be enlarged to perform the first osteotomy, care is taken to avoid important structures on the receiving bone Pilot holes are drilled. The pilot hole is then enlarged using a progressively widening expander device called an osteotome and manually advanced by the surgeon (typically 3 depending on the width and length of the implant). From one to seven consecutive enlargement steps). Once the receiving hole is properly created, the fixation screw (typically self-tapping) is placed with the correct torque so that the surrounding bone is not overloaded.

  Osteotome technology has begun to be widely used in certain situations that require pretreatment of the osteotomy site by enlargement of the pilot hole. Originally, osteotome technology is a traumatic procedure. The osteotome is originally a non-rotating device, rather advanced by the impact of a surgical mallet, and in the process of preparing an osteotomy site that allows the placement of the implant, compacting the bone (compacting) ) And enlarge. For example, treatment of the mandibular region is often limited by the increased density and decreased flexibility (plasticity) that occurs in bone in this region. Other non-dental bone implant sites may have similar difficult density and flexibility characteristics. Or, to name just a few, the bone position may not be at all suitable for the severe impact of the osteotome, such as its application to small bones such as the vertebrae and hand / wrist regions. Furthermore, since conventional osteotomes are inserted using a hammer, the explosive nature of the impact force gives limited control to the enlargement procedure, for example unintentional misalignment in the labial bone in dental applications. And often cause fractures. Many patients cannot tolerate osteotome technology and often complain about the impact of surgical mallet. In addition, the report causes various complications due to impact trauma in dental applications, such as dizziness and eye nystagmus (ie, the involuntary periodic movement of the eyeball in all directions) It is described.

  Recently, an alternative technique for osteotome with hammers has been developed for bone applications, which can reduce traumatic preparation of the implant site. These alternative treatments are based on the use of motor-driven, screw-type bone expanders, such as products sold by MEIsinger (Neuss, Germany). First, a pilot hole is drilled in the implant site, and then a continuous, progressive expander screw tap is introduced into the bone by hand or motor driven rotation. This reduces surgical trauma (compared to a hammer tap) while providing some degree of control over the enlarged site. The thread pattern of the expander screw tap is intended to consolidate the bone laterally as the expander tap advances to the bone crest. This system allows for the expansion and preparation of Type II and III implant sites and the compaction of Type IV bones.

  ANITUA ALDECOA, US Application No. 2006/0121415, describes the use and method of a motor-driven tool for enlarging a human bone for the purpose of attaching a dental implant. Similar to the progressive embodiment above, a starter drill to create a pilot hole and then insert an expander screw tap type osteotome having a cone / cylindrical shape in progressive cross section Is used. A surgical motor is used to rotate the osteotome at a relatively low speed. Another example of this technique is described in US Pat. No. 7,541,144 issued July 10, 2007 to NILO et al. U.S. Patent Application No. 2006/0121415 and U.S. Patent No. 7,241,144 are incorporated by reference in their entirety.

  US Pat. No. 7,402,040 issued July 22, 2008 to TURRI discloses a hybrid hammering and rotating osteotome technique using a non-circular osteotome structure. In a preferred embodiment, the non-circular osteotome is struck at the base (bottom) of the osteotomy and then, when full depth is reached, the non-circular osteotome is manually rotated back and forth to create the final enlarged shape. . However, in another embodiment, impact hammering and rotation are applied simultaneously to bring the osteotome deeper into the osteotomy. Advancement to osteotomy is facilitated by a helical end that generates a “traction force” that facilitates the advancement of the osteotome towards the interior of the bone site (TURRI column 9, lines 42-43). reference). In other words, the osteotome of another embodiment of TURRI uses a screw thread with a combination of impulse hammering and electric rotation to pull the osteotome down for osteotomy.

  In prior art structures including motor driven bone enlargement and the above-mentioned inventions of ANITUA ALDECOA, NIRO and TURRI, the rotational speed of the expander screw tap is fixed in a predetermined relationship with the osteotomy expansion speed. . This is because the screw thread of the expander device enters the bone and, by rotation, “pulls” the expander tap deeply to the initial osteotomy site. Thus, axial advancement is controlled by the thread pitch and rotational speed. The pitch of the expander thread is fixed and cannot be changed by the surgeon accordingly. If the surgeon wants to expand the bone more slowly, the only option is to turn the expander slower. Conversely, if the surgeon wants to expand the bone faster, the only option is to turn the expander tool faster. Thus, the speed of bone expansion is a direct and unchangeable function of the speed at which the surgeon turns the expander tool. Also, the surgeon cannot change other parameters such as pressure and / or rotational speed in order to achieve an optimal magnification rate.

  The unavoidable relationship between tool rotation speed and bone expansion speed in all prior art rotary expander systems limits surgical control during the implant process and, in some cases, is an unnecessary patient. Can lead to discomfort. Therefore, the art expands osteotomy sites that accept implants that provide higher surgical control, less cost, less error, and less patient discomfort in all bone applications. There is a need for improved surgical procedures and tools used therein.

  Another area of interest for bone preparation for receiving an implant or fixation screw is the subsequent osseointegration of the implant. The direct structural and functional connection between the living tooth and the load bearing artificial implant surface has resulted in an overall increase in surgical success to the patient. Modern approaches to improve direct contact between bone and the implant surface typically involve the use of engineered cements and / or patent-protected implant surfaces, including porous structures. It is targeted. The porosity of the implant surface contributes to extensive bone infiltration and allows osteoblast activity to take place. Furthermore, the porosity allows soft tissue attachment and angiogenesis within the implant. A significant disadvantage of modern approaches aimed at improving osseointegration, ie the use of cement and implant structures, is the relatively high additional cost. Cement and engineering implants are often patent-protected products that are sold at a premium. For example, when applied to standard fixation, it is not uncommon for a bone screw to cost US $ 5000.

  Accordingly, there is a need for improved tools and techniques that facilitate osseointegration without the associated high costs of current cement and engineering implants.

  In addition, other types of cellular materials, such as metal foams used in some aerospace applications, are also derived from the concept of pore formation used in the medical field for bone building. Requires fixed technology that can benefit.

  According to a first aspect of the invention, the rotary osteotome is configured to be continuously rotated in one direction so as to enlarge the osteotomy site by grinding (polishing). The rotary osteotome includes a shank (shaft portion) that forms a vertical axis for rotating the rotary osteotome. The body is coupled to the shank. The body has a tip that is distal to the shank and has a conical tapered shape (contour) that decreases from a maximum diameter close to the shank to a minimum diameter close to the tip. The tip includes at least one cutting edge. A plurality of grooves are arranged around the main body. Each groove has a grinding surface and an opposite cutting surface. A land is formed between adjacent grooves. Each land has a land surface that joins a ground surface of one groove and a cut surface of an adjacent groove. The at least one cutting edge and land are configured to continuously rotate in the grinding direction and simultaneously generate an opposite axial reaction force when forcibly advanced toward the osteotomy site. The opposite axial reaction force is directional opposite to the direction of forceful advancement toward the osteotomy site, thereby pushing the osteotome back against the surgeon in the enlargement procedure. This reversal phenomenon provides the surgeon with a high degree of restraint in the enlargement procedure and effectively decouples the speed of bone expansion and tool rotation.

  According to a second aspect of the invention, the rotary osteotome is configured to be continuously rotated in one direction so as to enlarge the osteotomy site by grinding. The rotary osteotome includes a shank having an elongated cylindrical shaft. The body is coupled to the shank. The body has a tip distal to the shank and has a conical taper shape that decreases from a maximum diameter close to the shank to a minimum diameter close to the tip. The tip includes at least one cutting edge. A plurality of grooves are arranged around the main body. Each groove has a grinding surface and an opposite cut surface. A land is formed between adjacent grooves. This cutting edge is continuously rotated at high speed in the grinding direction, and is configured to simultaneously perform bone autograft and compression molding (compacting) when forcibly advanced toward the osteotomy site. (I.e., gently push the bone structure laterally and outwardly in the condensation mechanism). The self-implantation and pressing operation of the cutting edge allows the rotary osteotome to gradually move from the top to the bottom of the bone while maintaining the beneficial properties that allow the shaved aggregate to be implanted directly into the osteotomy site. Allows the cutting site to be enlarged, thereby facilitating bone bonding of subsequently placed implants or fixation members.

  According to a third aspect of the present invention, the rotary tool is configured to be continuously rotated in one direction so as to enlarge the hole in the spongy material (not limited to bone) by grinding. The rotary tool includes a shank that defines a longitudinal axis of rotation of the rotary tool. The body is coupled to the shank. The body has a tip that is distal to the shank and has a conical taper shape that decreases from a maximum diameter proximate the shank to a minimum diameter close to the tip. The tip includes at least one cutting edge. A plurality of grooves are arranged around the main body. Each groove has a ground surface and an opposite cut surface. A land is formed between adjacent grooves. Each land has a land surface that joins a ground surface of one groove and a cut surface of an adjacent groove. The at least one cutting edge and land are configured to continuously rotate in the grinding direction and to generate opposite axial reaction forces when forced toward the osteotomy site. This phenomenon of pushing back (pushback) provides the user with a high restraining force in the enlargement procedure and effectively decouples the bone enlargement speed and the tool rotation.

  According to a fourth aspect of the invention, the ultrasound osteotome is configured to enlarge the osteotomy site. The ultrasonic osteotome includes a shank. The body is coupled to the shank. The body has a tip that is distal to the shank and has a conical taper shape that decreases from a maximum diameter proximate the shank to a minimum diameter close to the tip. The tip includes a unidirectional grinding structure. The autograft ramp (ramp, ramp) is forced to advance toward the osteotomy site with high-frequency vibration, and at the same time the bone is pulverized with ultrasound, then the bone is autografted and pressed (compact). Ting).

  According to a fifth aspect of the present invention, a method for enlarging an osteotomy site by grinding is provided. The method includes supporting a grooved body for rotation about a longitudinal axis. The body has a tip and has a conical taper shape that decreases from a maximum diameter to a minimum diameter close to the tip. Further, the method includes forcing the body to advance to the osteotomy site and continuously rotating the body in the grinding direction. Improvements include progressively grinding a larger amount of aggregate at the tip while the body is advanced deeper into the osteotomy site, ground to the host bone in the osteotomy site The steps include autografting the aggregate and pressing (compacting) the ground aggregate in the osteotomy site into the receiving bone with a fluted body. The autograft and compression operation provides a rotational osteotome progressively in the axial direction from top to bottom while maintaining the beneficial properties that allow the shaved aggregate to be immediately transplanted to the osteotomy site. Can be enlarged, thereby facilitating bone bonding of the placed implant or fixation member.

  According to a sixth aspect of the invention, a method is provided for enlarging an osteotomy site by grinding. The method includes supporting a grooved body for rotation about a longitudinal axis. The body has a tip and has a conical taper shape that decreases from a maximum diameter to a minimum diameter close to the tip. Further, the method includes forcing the body to advance to the osteotomy site and continuously rotating the body in the grinding direction. The improvements include a step of progressively grinding a larger amount of aggregate at the tip while the body is advanced deeper into the osteotomy site, and a direction opposite to the direction of travel of the body toward the osteotomy site. Generating an opposite axial reaction force. The opposite axial reaction force is directional opposite to the direction of forceful advancement toward the osteotomy site, thereby pushing the osteotome back against the surgeon in the enlargement procedure. This reversal phenomenon provides the surgeon with a high degree of restraint in the enlargement procedure and effectively decouples the speed of bone expansion and tool rotation.

These and other features of the present invention will be more fully understood upon review of the detailed description and figures of the present invention.

  These and other features and advantages of the present invention will be more readily understood when considered in conjunction with the following detailed description and the accompanying drawings.

FIG. 1 represents an exemplary application of the present invention in an edentulous (toothless) jaw position that needs to be enlarged to receive an implant.

FIG. 2 represents the osteotomy site that has been implemented using the present invention in the gradual series of enlargement steps in FIG.

FIG. 3 represents a gradual expansion step in FIG. 1 using a rotary osteotome according to one embodiment of the present invention.

FIG. 4 shows that, in FIG. 2, the attached implant is ready for pretreatment to receive the abutment or base of a prosthesis (not shown) to be subsequently attached.

FIG. 5 illustrates, by way of example, a bi-directional procedure for simultaneously preparing a surgical kit including four progressively increasing osteotomes according to the present invention and three remote osteotomy sites in a human jaw. It is the diagram which showed the usage method of this drill motor. The osteotome direction is selectively reversed and used to enlarge each osteotomy site by either cutting or grinding without removing the osteotome from the surgical drill motor.

FIG. 6 is a side view of a rotary osteotome according to one embodiment of the present invention.

FIG. 7 is a simplified cross-sectional view representing a surgical procedure, hereinafter referred to as “bounce”, where the surgeon adjusts the magnification rate (and other factors) on an as-needed basis. The osteotome continues to rotate repeatedly so that the osteotomy site can be enlarged while allowing manipulation, while the osteotome according to the present invention is repeatedly pushed into the osteotomy site and pulled out.

FIG. 8 illustrates the penetration depth to the osteotomy site (or hole) in three different procedures to illustrate that the surgeon (or user) can adjust the advancement force flexibly depending on the particular situation. FIG. 5 is an exemplary graph representing the force applied by the user to advance the body to the osteotomy site.

FIG. 9 is a simplified stress strain curve that generally represents bone, metal foam, or other matrix suitable for use with the present invention.

FIG. 10 is an enlarged view of the distal end portion of the rotary osteotome according to one embodiment of the present invention.

FIG. 11 depicts a cross-sectional view of an osteotomy site including a rotating osteotome partially disposed therein during an enlargement procedure according to the present invention.

FIG. 12 is an enlarged view of the region defined by 12 in FIG. 11, which is the reaction force (R) applied to the rotary osteotome by the bone wall in response to the rotation of the osteotome in the grinding direction. Is enhanced.

FIG. 13 is a chart of the reaction force (R) in FIG. 12, and is shown separately for lateral force (Rx) and axial force (Ry).

FIG. 14 is a partial perspective view of a distal end portion of a rotary osteotome according to an embodiment of the present invention.

FIG. 15 is an end view of the distal end of the rotary osteotome of FIGS.

FIG. 15A is a cross-sectional view of the tip of the osteotome according to the present invention generally along the semicircle 15A-15A of FIG.

FIG. 16 is an enlarged view of a land defined by 16 in FIG.

FIG. 17 shows the rotational osteotome tips seen at various stages of the enlargement procedure to describe the area of the osteotomy site where grinding, pressing and autografting are performed at each stage of the enlargement process. FIG. 5 is an exaggerated cross-sectional view of the accompanying osteotomy site.

FIG. 18 is a cross-sectional view taken generally along line 18-18 of FIG.

FIG. 19 is a cross-sectional view taken generally along line 19-19 in FIG.

FIG. 20 is an enlarged view of the region defined by 20 in FIG. 17 and illustrates features of bone grinding and autograft at the tip.

FIG. 21 is a partial perspective view of the tip of FIG. 14, but from a slightly different point of view, showing the region of the tip where bone material has gathered and then is returned to the surrounding bone. It is shown.

FIG. 22 is a micro CT image taken during testing of the template rotating osteotome of the present invention, (A, left) prior art bar, (B, center) rotation of the present invention rotating in the cutting direction. FIG. 3 shows a lateral slice of the porcine 03 medial tibial plateau with a comparison hole created by the rotary osteotome of the present invention and the rotating osteotome of the present invention rotating in the grinding direction (C, right).

FIGS. 23A-D are micro-CT images taken during testing of the template rotating osteotome of the present invention, the prior art bar (FIG. 23A), and the rotating osteotome of the present invention rotating in the grinding direction (FIG. 23C) produced by the axial slice of the porcine 03 tibial medial plateau, the prior art bar (FIG. 23B) and the rotating osteotome of the present invention rotating in the grinding direction (FIG. 23D). FIG. 6 is a comparative axial slice view of an average bone mineral projection of a 1 cm volume around the 02 inner hole.

FIG. 24 represents another embodiment of the osteotome of the present invention constructed with high frequency vibrations rather than rotation.

FIG. 25 is a cross-sectional view of another osteotome osteotomy site of FIG. 24 arranged to partially perform an enlargement procedure according to the present invention.

FIG. 26 is an enlarged view of a tip portion of another osteotome of FIG.

FIG. 27 is a simplified illustration of the human skeleton highlighting some examples of areas where the novel osteotome of the present invention may be effectively applied.

FIG. 27A is an enlarged view of the human spine.

27B is a cross-sectional view of the spine of FIG. 27A, according to one embodiment of the present invention, arranged to enlarge an osteotomy site intended to receive a fixation screw or other implant device. Includes a rotating osteotome.

FIG. 28 is a perspective view of a perforated metal foam using a rotating osteotome according to the present invention illustrating at least one exemplary commercial application.

Referring to the drawings, like numerals indicate like or corresponding parts throughout the several views. FIGS. 1 to 4 show examples of dental implants, and pre-treatment of the osteotomy site is required to receive the bone implant (FIG. 4). Of course, the present invention is not limited to dental applications, but can be applied to a wide range of orthopedic applications. Furthermore, the present invention is not limited to bone or orthopedic applications, but can be used to prepare holes in metal foam and other spongy materials, such as for industrial and commercial applications. In FIG. 1, there is an edentulous (toothless) jaw position 30 that needs to be expanded and prepared as an osteotomy site 32 (FIG. 2) to receive an implant 34 or other fixation device (FIG. 4). Indicated. The sequential steps include first drilling a pilot hole in the receiving bone to form an initial osteotomy site, and then a progressively widening rotary type, generally indicated at 36, as shown in FIG. Incremental expansion of the osteotomy site using an expander device is included. Once the osteotomy site is prepared, the implant 34 or fixation screw is screwed into place as illustrated in FIG. Procedures for the formation of osteotomy sites are described in HUWAIS US Patent Application No. 2013/0004918, issued January 3, 2013, the entire disclosure of which is incorporated by reference.

  FIG. 5 illustrates, by way of example, a treatment set comprising four progressively increasing osteotomes 36A-36D according to the present invention, three remote osteotomy sites 32A, 32B in a human jaw, and It is the diagram which illustrated the usage method of the bidirectional | two-way drill motor 38 for preparing 32C each simultaneously. Without removing the osteotome 36 from the treatment drill motor 38, the orientation of the osteotome is selectively reversed and used to enlarge each osteotomy site by either cutting or grinding. Although this example is shown again for dental applications, those skilled in the art will appreciate that techniques described herein include general joint replacement, bone fixation, and foam metal (see FIGS. 27B and 28). Of course, it will be understood that the present invention can be applied to applications other than the dental field.

  Returning to the example of FIG. 5, the first osteotomy site 32 </ b> A is located in front of the mandible 30 having a relatively narrow bone width. The composition of bone 30 in the region of first osteotomy site 32A can be primarily of type II. The second osteotomy site 32 </ b> B is located slightly behind the first site 32 </ b> A of the lower jaw region having the narrow bone 30. The composition of bone 30 in the region of second osteotomy site 32B can generally be a mixture of Type II and III. The third osteotomy site 32C is located in the lower molar region, and is surrounded by a relatively wide bone 30. The composition of the bone 30 in the region of the third osteotomy site 32C may be primarily type III. Due to the difference in bone 30 width and composition at the sites 32A, 32B and 32C, the surgeon does not want to apply the exact same technique or procedure to each osteotomy site 32. By using the present invention, the surgeon (or non-surgical application user) can prepare all three osteotomy sites 32A-32C simultaneously by different means.

  In this example, each osteotomy site 32A-32C is presumed to have an initial osteotomy site prepared by first drilling a 1.5 mm pilot hole. Regardless of dentistry, any surgical application situation will determine the dimensions of the initial osteotomy site and other surgical characteristics). The surgeon locks (fixes) or installs the first osteotome 36A on the drill motor 38 and sets the rotation direction counterclockwise. The surgeon can change the rotation speed of the osteotome 36 according to the determination of the corresponding situation in their judgment, but experimental results show that a rotation speed of about 200-1200 RPM and a torque setting of about 15-50 Ncm are good results. Show that it brings. More preferably, a rotational speed of about 600-1000 RPM and a torque setting of about 20-45 Ncm yield good results. More preferably, a rotational speed of about 800-900 RPM and a torque setting of about 35 Ncm yield good results.

  The surgeon then pushes the rotating first osteotome 36A into the first osteotomy site 32A for enlargement by grinding (details will be described later). However, due to the different compositional characteristics of the second osteotomy site 32B and the third osteotomy site 32C, the surgeon chooses to enlarge by cutting rather than grinding. In order to reflect this, the surgeon reverses the direction of rotation of the drill motor 38 clockwise without removing the first osteotome 36A from the drill motor 38. The surgeon then uses a similar pressing action to remove aggregates that may be harvested as needed, thereby providing a second osteotomy site 32B and a third osteotomy site 32C. To enlarge.

  At this stage in this hypothetical example, the first osteotomy site 32A has been enlarged to the size desired by the surgeon, and no further expansion is required for the first osteotomy site 32A. However, the second osteotomy site 32B and the third osteotomy site 32C both require additional enlargement. The surgeon then attaches the second osteotome 36B to the drill motor 38 and sets the direction of rotation counterclockwise. The surgeon skips the completed first osteotomy site 32A and deploys the second osteotome 36B to the second osteotomy site 32B by grinding. Because of the different composition characteristics of the third osteotomy site 32C, the surgeon chooses to enlarge by cutting rather than grinding. In order to reflect this, the surgeon reverses the rotation direction of the surgical motor 38 clockwise without removing the second osteotome 36B from the drill motor 38. The surgeon then uses a similar pressing action to enlarge the third osteotomy site 32C by removing the aggregate (which may be removed if necessary).

  When the second osteotomy site 32B and the third osteotomy site 32C are enlarged with the second osteotome 36B, the surgeon locks or attaches the third osteotome 36C to the drill motor 38 and reverses the direction of rotation. Set clockwise. The completed first osteotomy site 32A is skipped again, and the second osteotomy site 32B and the third osteotomy site 32C are enlarged by grinding. In any case, the surgical motor 38 is set to rotate counterclockwise. At this point, the second osteotomy site 32B has been expanded to the size desired by the surgeon, and no further expansion is required for the second osteotomy site 32B. However, the third osteotomy site 32C requires additional enlargement. Therefore, the surgeon installs the fourth osteotome 36D on the drill motor 38 and sets the rotation direction counterclockwise. The third osteotomy site 32C is enlarged by skipping the completed first osteotomy site 32A and the second osteotomy site 32B and grinding using the technique described above. At this point, the implant 34 (or a fixed portion of the implant) can be placed in each of the osteotomy sites 32A to 32C. The surgeon adds a 3.0 mm to 3.25 mm implant (not shown) to the first osteotomy site 32A, a 5.0 mm implant (not shown) to the second osteotomy site 32B, and A 6.0 mm implant (not shown) is placed at the third osteotomy site 32C. The surgeon does not remove the osteotome 36 from the drill motor 38, but has the ability to expand one part by grinding and another part by cutting, while providing a plurality of osteotomy sites 32A, 32B, 32C ... 32n. Can be prepared at the same time. Thus, the rotary osteotome 36 is configured to be rotated in one direction at high speed to expand the osteotomy with grinding and to rotate in the opposite direction to expand the osteotomy with cutting. Has been.

  Turning now to FIG. 6, an osteotome 36 including a shank 40 and a body 42 is shown in accordance with one preferred embodiment of the present invention. The shank 40 has an elongated cylindrical shaft that defines the longitudinal axis of rotation A of the rotary osteotome 36. A drill motor engaging interface 44 for connection with the drill motor 38 is formed at the distal end of the shaft. The particular configuration of interface 44 can vary depending on the type of drill motor 38 used. Also, the particular configuration of the interface 44 may in some cases be just a smooth part of the shaft that can be gripped by three or four jaw collets. The main body 42 is joined to the lower end of the shank 40, and this joint can be formed by a tapered or dome-like transition 46. The main switching unit 46 acts like an umbrella when the surgeon pours (washes) water with water during treatment. The gentle switching portion 46 facilitates water flow (not shown) to the osteotomy site while minimizing water splashing or diversion while the osteotome 36 is rotating.

  The body 42 has a conical taper shape that decreases from a maximum diameter adjacent the shank 40 to a minimum diameter adjacent the tip 48. Thus, the tip 48 is separated from the shank 40. The working length or effective length of the main body is proportional to the taper angle and the size and number of osteotomes (36A, 36B, 36C, 36D... 36n) included in the kit. Preferably, all of the osteotomes 36 of the kit have the same taper angle, and preferably the diameter at the upper end of the body 42 of one osteotome (eg 36A) is the body 42 of the next larger size osteotome (eg 36B). Is approximately equal to the diameter adjacent to the tip. Taper angles between about 1 ° and 5 ° (or more) are possible depending on the application. More preferably, a taper angle between about 2 ° and 3 ° will give good results. And more preferably, a taper angle of 2 ° 36 'is known to provide remarkable results within dental applications within the typical requirements for the length of body 42 (eg, about 11 mm to 15 mm). It is done.

  The tip 48 is defined by at least one, preferably a pair of cutting edges (lip) 50. The cutting edge 50 is actually a cutting edge (edge) disposed on the opposite side of the tip 48, but in the illustrated embodiment, it is not located in a common plane. In other words, as shown in FIGS. 14 and 15, the cutting edge 50 is (in terms of direct diametrical alignment) by a short chisel point 52 extending centrally through the longitudinal axis A. Slightly off. While the chisel point 52 is a common feature found in drill tools, the construction of an alternative tip 48 for the chisel point 52 is naturally possible, including circular and simple pointed shapes. As described above, the cutting edge 50 is a cutting edge that is angled upward and downward (in the radial direction) from the tip portion 48. The angle of the cutting edge 50 can be varied to optimize the performance of a particular application. In practice, the cutting edge angle may be measured at about 60 ° relative to the longitudinal axis A, or may be measured at 120 ° between two opposing cutting edges 50.

  Each cutting edge 50 has a generally planar first trailing flake 54. The first skirt-like side portions 54 are positioned at an angle from the respective cutting edges 50 at a first angle. The first angle may vary to optimize for performance and specific applications. In fact, it may be about 45 ° with respect to the longitudinal axis A, or 90 ° between the two opposing first skirt sides 54. Thus, two opposing first skirt sides 54 are mounted in opposite directions so that when the osteotome 36 is rotated in use, the first skirt sides 54 are each cut edge 50. It is natural that either lead (lead) or follow after the cutting edge. When the first skirt-like side portion 54 leads each cutting edge 50, the osteotome is said to rotate in the grinding direction. On the other hand, when the first skirt-like side portion 54 follows each cutting edge 50, the osteotome rotates in the cutting direction. That is, it is said that the leading cutting edge 50 cuts or slices the bone. In the grinding direction, the cutting edge 50 is such that the first skirt side 54 is actually in contact with the cutting edge 50 to minimize bone (or other matrix) debris formation and shear deformation. A large negative rake angle (see examples in FIGS. 17 and 20).

  The substantially planar second skirt-like side portion 56 is formed adjacent to each first skirt-like side portion 54 at a second angle smaller than the first angle, and is located away from each other. In the example in which the first skirt-like side portion 54 is formed at 45 ° (relative to the axis A), the second skirt-like side portion 56 may be smaller than 40 °. A generally planar relief pocket 58 is formed adjacent to each second skirt side 56 at a third angle that is less than the second angle and is spaced apart from each other. In the example where the second skirt-like side portion 56 is formed at 40 ° (relative to axis A), the relief pocket 58 (ie, the third angle) may be smaller than 30 °. Each relief pocket 58 is disposed in the area of the tip 48 between the second skirt side 56 and the cutting edge 50. A generally axially arranged cutting edge surface 60 extends between the relief pocket 58 and the adjacent cutting edge 50. This is probably best shown in the enlarged view of FIG. When the osteotome 36 is rotated in the cutting direction, a large amount of bone debris is collected in the area of the relief pocket 58. When the osteotome 36 is rotated in the grinding direction, very little or no bone debris is collected in the area of the relief pocket 58.

  FIG. 15A is a highly simplified and exemplary cross-sectional view of the tip 48 of the osteotome 36, taken generally along 15A-15A of FIG. In this simplified illustration, small points are given at the intersections of the planes. This point does not actually exist, but has been added to this drawing to highlight the boundaries of the different planes (54, 56, 58, 60). In combination with several other drawings and descriptions, FIG. 15A shows various facets (facets, 54, 56, 58, 60) and their relation to each other, and the facets and cutting edges 50. This relevance is made known to those skilled in the art.

  A plurality of grooves 62 are arranged around the main body 42. The grooves 62 are preferably mounted evenly around the body 42, but are not limited thereto. The diameter of the body 42 can affect the number of grooves 62. As an example, a body 42 in the range of about 1.5 mm to 2.8 mm can be formed with 3 or 4 grooves. A body 42 in the range of about 2.5 mm to 3.8 mm can be formed with 5 or 6 grooves. A body 42 in the range of about 3.5 mm to 4.8 mm can be formed with 7 or 8 grooves. A body 42 in the range of about 4.5 mm to 5.8 mm can be formed with 9 or 10 grooves. Of course, the number of grooves 62 may vary more or less compared to the examples listed here to optimize performance and / or better adapt to a particular application.

  In the illustrated embodiment, the groove 62 is formed by a helical twist. If the cutting direction is the right hand (clockwise) direction, preferably the helix is also the right hand direction. The RHS-RHC structure is shown throughout the drawings, although it should be understood that reversal of the cutting direction and helical direction (ie, LHS-LHC) can be achieved with substantially equivalent results, if desired. Yes. The diameter of the body 42 can affect the angle of the helix. As an example, a body 42 in the range of about 1.5 mm to 2.8 mm can be formed with a 9.5 ° angle. A body 42 in the range of about 2.5 mm to 3.8 mm can be formed with an 11 ° angle. A body 42 in the range of about 3.5 mm to 4.8 mm can be formed with a 12 ° angle. A body 42 in the range of about 4.5 mm to 5.8 mm can be formed with a 12.5 ° angle. Of course, the spiral angle may vary more or less compared to the examples given here to optimize performance and / or better adapt to a particular application.

  Each groove 62 has a grinding surface 64 and an opposing cutting surface 66, perhaps as best shown in FIGS. Ribs or lands are otherwise formed between adjacent grooves 62. Therefore, for example, the osteotome 36 of the four grooves 62 has four lands, and the osteotome 36 of the ten grooves 62 has ten alternating lands. Each land has an outer land surface 70 extending between the grinding surface 64 of the groove 62 on one side and the cut surface 66 of the groove 62 on the opposite side. The end-like contact between each land surface 70 and its associated cut surface 66 is called a working edge 72. Depending on the direction of rotation of the osteotome 36, the working end 72 may function to either cut the bone or grind the bone. That is, when the osteotome is rotated in the cutting direction, the working end 72 slices and digs out bone (or other matrix). When the osteotome rotates in the grinding direction, the working end 72 presses the bone (or other matrix) with little or no cutting and moves in the radial direction. This pressing and radial movement is shown as gentle pushing in the lateral and outward direction of the bone structure in the condensation mechanism. FIG. 15 illustrates a web 74 that overlaps as a broken circle. The web circle 74, or simply the web 74, is the base or central portion of the body 42 to which all lands connect. The diameter of the web circle 74 varies with the tapered diameter of the body 42.

  In the preferred embodiment, the working end 72 has substantially no margin and the entire land surface 70 is cut behind the working end 72 to provide complete clearance. In standard prior art bars and drills, a margin is typically integrated behind the working end to guide the drill into the hole and maintain the diameter of the drill. The primary taper clearance angle, ie, the angle between the tangent of the working end 72 and each land surface 70, as shown in FIG. 16, can be between about 1 ° and 30 ° depending on the application. Can be. More preferably, the primary tapered relief angle is between about 5 ° and 20 °. The diameter of the body 42 can affect the primary tapered clearance angle. As an example, a body 42 in the range of about 1.5 mm to 2.8 mm can be formed with a primary tapered relief angle of 15 °. A body 42 in the range of about 2.5 mm to 3.8 mm can be formed with a primary tapered relief angle of 15 °. A body 42 in the range of about 3.5 mm to 4.8 mm can be formed with a primary tapered relief angle of 12 °. A body 42 in the range of about 4.5 mm to 5.8 mm can be formed with a primary tapered relief angle of 10 °. Of course, the primary tapered relief angle may vary more or less compared to the examples listed here to optimize performance and / or better fit a particular application. As described above in connection with the helical twist angle, for example, in FIG. 14, the substantially marginless working end 72 has a grinding direction as the diameter decreases due to the conical taper of the body 42. Deviate from (go to the other side). In other words, as shown in FIG. 14, when the grinding direction is counterclockwise, the helically twisted portion of the working end 72 is counterclockwise when viewed from the top of the main body 42 toward the tip 48. Become. Or, conversely, the twisted portion is seen in the clockwise direction when viewed from the tip 48 to the top of the main body 42. Thus, when the grinding direction is counterclockwise, when all the land surfaces 70 and the grooves 62 circulate around the longitudinal axis A in the counterclockwise direction, the working end 72 is located in the downward direction of the tip 48 and each land surface In order to trace (trace) 70 and the groove 62, the working end 72 "turns away from the grinding direction".

  The cut surface 66 forms a rake angle for each working end 72. The rake angle is an inclination angle measured from the tip surface of the tool (in this case, the working end 72) to a virtual line extending vertically from the surface of the work target (for example, the inner bone surface of osteotomy). The rake angle is a parameter used for various types of cutting and machining, and represents the angle of the cut surface with respect to the work target. The rake angle can be positive, negative, and zero degrees. The rake angle of the working end 72 is preferably zero (0) when rotating in the cutting direction. In other words, the cutting surface 66 is oriented generally perpendicular to the tangent of the arc scribed through the working end 72. As shown in FIG. 16, this creates a sharp cutting edge 72 that is very suitable for cutting / slicing bone when the osteotome 36 is rotated in the cutting direction.

  However, when the osteotome 36 rotates in the grinding direction, the rake angle is formed between the working end 72 and the land surface 70 and, as described above, becomes a large negative rake angle in the order of (for example) 10 ° to 15 °. . The large negative rake angle of the working end 72 (when rotating in the grinding direction) causes the wall of the osteotomy 32 to generate a compression wave before the point of contact, as if buttering the toast. And an outward pressure is applied at the point of contact between the working end 72. The downward pressure applied by the surgeon is necessary to keep the working end 72 in contact with the bone surface of the osteotomy to be expanded, i.e., to press against the working end 72 compression wave. The above is aided by the osteotome and the taper effect of the tool 36 creating a lateral (ie, intended direction of expansion) pressure. The stronger the surgeon presses, the more pressure is applied in the lateral direction. This allows the surgeon to fully control the magnification rate without greatly depending on the rotational speed of the osteotome 36. Accordingly, the strength of the grinding effect depends on the amount of force applied to the osteotome 36. As more force is applied, faster magnification is performed.

  When the working end 72 retracts the bone, the force on the working end 72 can be broken down into two component forces. One is perpendicular to the surface of the bone, pressing the bone outward, and the other is tangent, pulling the bone along the internal surface of the osteotomy. As the tangential component increases, the working end 72 begins to move smoothly along the bone. At the same time, normal drag deforms softer bone material. When the normal drag is low, the working end 72 is rubbed against the bone but does not permanently change its surface. This frictional action creates resistance and heat, which can be controlled by the surgeon by changing the rotational speed and / or pressure and / or water injection on an as-needed basis. Because the body 42 of the osteotome 36 is tapered, the surgeon can move the working end 72 away from the bone surface at any time during surgery to allow air cooling and / or water injection. This can be done by a controlled “repulsive force” that is continuously applied by a surgeon who continuously monitors progress and makes fine corrections and adjustments. See FIGS. 7 and 8, which illustrate that various forces and capabilities to lift the osteotome out of engagement with the wall of the osteotomy 43 can be applied at any time during the procedure. As the downward force applied by the surgeon increases, the pressure at the bone surface eventually exceeds its yield strength. Beyond the yield strength, the working end 72 digs into the surface and creates a recess behind it. Thus, this action of digging the working end 72 groove progressively enlarges the osteotomy.

  FIG. 9 represents a typical illustrative stress-strain curve of bone and other ductile materials including, but not limited to, foam metals of the type used for various commercial, industrial and aviation applications. The straight line portion of the curve from the origin (0, 0) to B represents the elastic response region of the material. Reference point B represents the elastic limit of the material. The elastic properties of bone are well known, but if the load applied by the surgeon does not exceed the ability of the elastically deforming bone, ie below the reference point B, the bone will immediately It will return to its original (undeformed) state. On the other hand, if the load applied by the surgeon exceeds the elastically deformable bone performance, the bone will deform and will permanently change shape due to plastic deformation. Permanent shape changes in bone are associated with microcracks that allow energy release and are thought to jeopardize the innate immunity to complete fracture. If these microcracks are small, the bone remains integral even when the osteotomy is expanded. The region of plastic deformation extends all the way from the yield point (C) of the material to the crushing point (E). The peak (D) of the curve between the yield point (C) and the crushing point (E) indicates the maximum tensile strength of the material. When a material (eg, bone or foam metal) is subjected to pressure in the region between its yield point (C) and maximum tensile strength (D), strain hardening occurs in the material. Strain hardening, also known as work hardening or cold work, is the strengthening of a ductile material by plastic deformation. This strengthening occurs due to the movement of the transition within the crystal structure of the material and the occurrence of the transition, and corresponds to the above-mentioned microcrack in the bone material. A material tends to necking when pressure is applied in the region between its maximum tensile strength (D) and the crushing point (E).

The direction of the helical twist can be designed to play a role in controlling the surgeon so that the optimal level of pressure can be applied to the bone (or other mother) during the enlargement procedure. Material). In particular, the above RHS-RHC structure shows a right helix for the cutting direction of the right hand (or alternatively, an LHS-LHC structure, not shown), and the osteotome 36 rotates at high speed in the grinding direction without interruption. However, it imposes a beneficial opposite axial reaction force (R _y ) when forcibly advanced to osteotomy 32 (manually by the surgeon) at the same time. This opposite axial reaction force (R _y ) is illustrated in FIGS. 11-13 in a direction opposite to the direction in which it is forced to advance in the direction of osteotomy 32. In other words, when the surgeon using the osteotome 36 urges the osteotome 36 downwardly toward the osteotomy 32, the opposite axial reaction force (R _y ) causes the osteotome to push upward, Work in the direction. The opposite axial reaction force (R _y ) is the vertical (or more precisely, “axis” relative to the vertical axis A) component of the reaction force (R), and this reaction force (R) is Newton's theory, “If there is an action, there is a reaction (ie, the third law of Newtonian motion)” added by the bone to the entire length of the working end 72 of the osteotome 36. Also, the opposite axial reaction force (R _y ), as shown in FIG. 20 and easily understood from FIG. 15A, when the osteotome 36 rotates in the grinding direction, Also caused by an effective large negative rake angle. Those skilled in the art will recognize that, in a preferred embodiment, both the cutting edge 50 and the working end 72 do not act in concert, but instead of either the cutting edge 50 alone or the construction of the working end 72 alone, the opposite axial direction. It will be appreciated that another embodiment in which a reaction force (R _y ) occurs.

When the osteotome 36 is rotating in the grinding direction, the surgeon plastically displaces / expands the bone as described above to advance the tip 48 to the bottom of the osteotomy 32. In addition to supplying the force necessary to), it must be pushed and overwhelmed against the opposite axial reaction force (R _y ). In other words, the osteotome 36 is designed so that the surgeon must work continuously against the opposite axial reaction force (R _y ) in order to enlarge the osteotomy by grinding. The opposite axial reaction force (R _y ) is beneficial, not detrimental to the surgeon, in that it provides greater control in the enlargement procedure. Thanks to the opposite axial reaction force (R _y ), the osteotome 36 is a standard “upcut” (up-cutting) designed to generate a traction force that tends to advance the osteotome into the bone site. The phenomenon of being pulled deeply into the osteotomy 32, as can occur with a twist drill or bar of “)” does not occur. These upcut bars grab the bar deeper into the osteotomy so that the surgeons will notice that they are raising themselves on a rotating bar to prevent excessive penetration. There is a possibility of pulling.

The strength of the opposite axial reaction force (R _y ) is always proportional to the strength of the force applied when the surgeon advances the body 42 into the osteotomy 32. This opposite force results in intuitive and natural, immediate haptic feedback to tell the surgeon at any moment whether force application is necessary, whether large or small. This simultaneous haptic feedback is extremely beneficial to the surgeon's delicate hand sensation by applying a reaction force (R, especially the axial component R _y ) transmitted directly through the osteotome 36. The mechanical simulation of the opposite axial reaction force (R _y ) is based on how the bone (or other matrix) reacts immediately to the enlargement procedure, allowing the surgeon to perform the extension procedure. Promote more advanced control.

Thus, the controlled “bouncing force” described above with respect to FIGS. 7-9 is more effectively and substantially further by the opposite axial reaction force (R _y ). Controllable, the surgeon can unintentionally monitor the progress without failing to control the speed of expansion, and can make occasional fine corrections and timely pressurization adjustments. Tactile feedback from the opposite axial reaction force (R _y ) allows the surgeon to intuitively apply pressure to the bone material, thereby providing a strain hardening region, ie, yield point (C) and There is preferably a strain response between the maximum tensile strengths (D). In any case, the surgeon will maintain a pressure (stress) above the elastic limit (B) and below the crushing point (E) (as generated by the force applied by the surgeon through the rotary osteotome 36). I will do my best. Of course, the bone will not be permanently deformed until the applied pressure passes the elastic limit (B). And the application of pressure above the crush point (E) will lead to bone (or other matrix) being destroyed in some cases.

The exemplary graph of FIG. 8 shows the surgical depth versus penetration depth to the osteotomy site 32 in order to advance the body 42 to the osteotomy site 32 in three different steps (ABC). It draws the power applied by the physician and shows how these ad hoc adjustments can be made according to the specific circumstances they face. As noted above, the applied force is a force manually generated by the surgeon, plus the opposite axial reaction force (R _y ) and the force required to expand / deform the bone. Is required. The applied force creates pressure on the bone (or other matrix), which causes the applied force to produce a strain response as shown in FIG. During the surgery, the surgeon uses his skills to manually change the applied pressure, so that the strain response remains in the plastic deformation region (BE), more preferably more ideal. In the typical strain hardening region (C-D). Therefore, the structure of the osteotome 36 of this embodiment produces a proportional opposite axial reaction force (R _y ) when the osteotome 36 rotates without interruption and simultaneously advances forward to the osteotomy 32. Is designed to give the surgeon additional controllability during the enlargement procedure (by grinding).

  Next, FIGS. 17-21 illustrate another new feature of the present invention. That is, when the osteotome 36 rotates at a high speed in the grinding direction without interruption and is forcibly advanced to the osteotomy 32 at the same time, the rotary osteotome 36 simultaneously self-implants bone and press-molds it. The feature of pressing (compacting, compacting) is defined as gently pressing the bone structure laterally and outwardly, thereby condensing the entire tissue surrounding the osteotomy site 32. sell. In FIG. 17, the osteotomy site 32 formed in accordance with the present invention is emphasized to emphasize the need to grind a small amount of bone (or other matrix) with each progressively growing osteotome 36. Are shown in an exaggerated taper state in order up to 7 ° (as compared to a preferred taper angle in the range of about 2 ° to 3 °).

  In FIG. 17, the surface 76 shows the inner wall of the osteotomy site 32 prepared by a smaller size osteotome 36 in a preceding enlargement procedure. Next, the tip 48 of the next larger size osteotome 36 is shown tangibly and is about to enter the osteotomy site, and virtually 2/3 has entered the osteotomy site 32. It will be appreciated that the osteotome 36 rotates at high speeds in the grinding direction (eg, counterclockwise in the previous example) at high speeds and is simultaneously forced to advance to the osteotomy site 32 by the surgeon's manual effort. The construction line 78 shows the cylindrical (ie, not tapered) passage of the tip 48, and the tip 48 moves from the top to the bottom within the osteotomy site 32. In other words, the diameter of the tip 48 does not change and therefore its passage also remains constant at the distance that the tip 48 moves. As substantively shown, when the osteotome 36 first enters the osteotomy site 32, the inner diameter of the previously created osteotomy site 76 is approximately equal to the diameter of the tip 48. However, the inner diameter of the previously produced osteotomy site 76 gradually decreases toward the bottom of the osteotomy site (ie, gradually decreases inward). However, as shown, the cylindrical passage of the tip 48 remains constant. Thus, as the osteotome 36 advances deeper toward the bottom of the osteotomy site 32, more bone is ground and / or bone to create space for the advanced (larger) osteotome 36. Is removed. A region 80 defined as an annular gap between the surfaces 76 and 78 (and a portion of the tip 48) is the outermost portion of the cutting edge 50 as the tip 48 advances to the full depth of the osteotomy site 32. Represents bone material that is ground by a blade. The ground or crushed area 80 includes not only the side wall of the osteotome 32 but also the lower end. In the next action (not shown), the tip is pressed against the bottom of the osteotomy site 32 when another osteotome 36 of the next larger size is used to further enlarge the osteotomy site 32. As a similar (but larger) region 80 appears, this continues in the same way.

  With continued reference to FIG. 17, the surface 82 shows the outer wall of the osteotomy site prepared by the expansion procedure of the osteotome 36, with the tip 48 of the osteotome 36 being physically and virtually illustrated. The surface 82 is substantially completely negative with respect to the pivoting osteotome body 42. In other words, the surface 82 will have the same taper as the osteotome body 42 and the bottom impression created by the rotating tip 48 of the illustrated osteotome. Region 84, defined as an annular gap between surfaces 78 and 82, represents bone material that is plastically removed by land working end 72 as osteotome body 42 advances to the full depth of osteotomy site 32. All bone material in region 84 is pressed radially and outwardly into the surrounding bone structure without cutting to represent a densified bone area.

  Here, an important view will be stated: "What happens to the ground / ground bone material that occupies the area 80?" As previously suggested, the osteotome 36 simultaneously autographs and presses the ground / ground bone in the region 80 as it rotates and is forced to advance to the osteotomy site 32. It is configured as follows. The autografting phenomenon supplements the basic bone pressing and condensation effects described above to further increase the density of the inner wall 82 at the osteotomy site. Furthermore, autograft, a process that reduces the patient's own bone material, accelerates recovery and enhances the body's natural healing properties to improve bone bonding.

  Next, FIG. 20 is an enlarged view showing a boundary line between the distal end portion 48 and the receiving bone material. At the position where each outermost blade of the cutting blade 50 that rotates and forcibly advances contacts the bone, abrasion causes the bone to be crushed. Bone debris is collected primarily at the second skirt side 56, that is, immediately behind each first skirt side 54. Some of the accumulated bone fragments travel radially and inward along the cutting edge 50 and are carried to the bottom of the osteotomy site 32. The remainder of the accumulated bone debris is carried along a groove 62 that meets the second skirt side 56 directly by pressure applied by the surgeon's manual pressing effort. This is illustrated in FIG. Although a small portion of bone fragments can leak into the relief pocket 58, it is of little importance. The bone debris carried to the groove 62 travels toward the land surface 70 where the bone debris has been wiped and pressed against the cellular walls of the osteotomy site 32. That is, implanting bone fragments into a patient's bone close to where the bone fragments were collected. The bone fragments carried to the bottom of the osteotomy site 32 are wiped off and pressed against the bottom of the osteotomy site 32. As a result, the autograft region 86 develops around and below the compression region 84, as shown in FIG. Interestingly, the autograft region 86 is thinnest where the compression region 84 is thickest, whereas the autograft region 86 is thickest where the compression region 84 is thinnest. An important feature of autograft 86 that serves to increase (and reliably stimulate) the area of osteotomy site 32 where density cannot be increased at the bottom of the osteotomy site with little or no pressing. There is an area. Therefore, the autograft phenomenon may be an ideal complement to the basic bone compaction and condensation effects in preparing the osteotomy site 32 to receive the implant 34 or other fixation device. Will be accepted.

In summary, the present invention describes a method for enlarging the osteotomy site 32 by grinding (or cutting if rotation is reversed). The basic steps of the present invention include supporting a grooved body 42 that rotates about a longitudinal axis A, the body 42 being reduced from a tip 48 and a maximum diameter adjacent to the tip 48 to a minimum diameter. It has a cylindrically tapered characteristic. The body 48 rotates without interruption in the grinding direction while the body 42 is simultaneously forced (by the surgeon's manual effort) to advance to the osteotomy site 32 at the same time. Notable improvements include progressively grinding more bone material at the tip 48 as the body 42 advances deeper into the osteotomy site 32 and osteotomy the crushed bone material. Autografting into the receiving bone in the site 32, pressing the compacted bone material into the receiving bone with a fluted body 42, and an opposing axial reaction force (R) _y ) is generated in a direction opposite to the direction in which the body 42 advances to the osteotomy site 32. The opposite axial reaction force (R _y ) is generated by the structure of the cutting edge 50 and / or the working end 72.

  The tools and techniques of the present invention are described as examples in, for example, POIRIER US Pat. No. 6,814,577, the entire disclosure of which is incorporated by reference, issued November 9, 2004, It can be easily adapted to the method of computer generated (CG) implant generated implant placement guides. Complying with these methods creates a computer model that provides structural details of the jawbone 30, shape information on the gum surface, and proposed prosthesis shape information for the tooth or dentistry. Since this computer model displays bone structure, gum surface and tooth images with reference to each other, the position of the osteotomy site 32 is selected taking into account correct positioning on the bone 30 and correct positioning on the implant 34. it can.

  These and other benefits are attributed to the details of an exemplary test describing the mechanical verification of bone grinding provided by the osteotome 36, and the following details regarding the methods previously described as surgical preparation and enlargement of the bone implant site. Will be understood.

(Example)
A mechanical test is performed using a surgical drill motor 38 and a material testing machine that controls rotational speed and depth penetration rate, while bone drilling / grinding The force and torque in the treatment to be measured were measured. In other words, the effects of the surgeon's manual operation were not included in the following test reports. Treatments using prior art bar drills, "grinding mode (osteotom for grinding)" grooved osteotome 36, and "drilling mode (osteotom drill)" grooved osteotome 36 were 3.8 mm or 6.0 mm. The insertion torque and the removal torque of the implant 34 were compared. A thermocouple was inserted 1 mm distal from the edge of the bone hole and heat generation during the drilling procedure was measured. Treatments included drilling with no irrigation (900 RPM), grinding with or without irrigation (200 RPM, 400 RPM, 600 RPM, 900 RPM, and 1100 RPM). The stability of the implant 34 was also measured by a resonance frequency analysis system from OSSTELL. Bone tissue around the hole is imaged with light microscopy and environmental scanning electron microscopy (ESEM®), and bone mineral density (BMD) and bone mass ratio (BVF) are microtomographic (micro CT) images. Specified by The final diameter of the prepared osteotomy site was measured at two depth levels 1 cm apart.

  A detailed standard operating procedure (SOP) was created and adhered to in all mechanical tests. Briefly, three porcine tibial plateau samples with articulating surfaces and removed subchondral bone (about 5 cm to 10 cm thick) are attached to an epoxy potting and custom clamp system. It was. The clamp was then secured to an ElectroPlus E10000® material testing system using a biaxial load cell for measurement of force and torque applied during the drilling / osteotomy procedure. A surgical drilling mechanism 38 with controllable motor speed and torque limiter (3i Implant Innovations, WS-75) was attached to the crosshead of the material testing system.

  The test system was programmed for displacement control with a constant linear velocity, moving forward and backward in progressive depth until a target depth of 13 mm bar / osteotome was reached. A step with 5 diameters was used to progressively enlarge the hole. Prior art surgical perforation bars with maximum diameters of 1.8, 2.8, 3.8, 4.8 and 5.2 mm are used, while grooved osteotome has a maximum diameter of 1.8, 2. 8, 3.8, 4.8 and 5.8 mm. After these enlargement steps were performed, a 6.0 mm diameter implant was inserted into the seven holes. In three cases, after the 3.8 mm step was completed, the 3.8 mm diameter implant was inserted and after the 3.8 mm implant was removed, the progressive expansion of the hole was continued.

  During the test, heat generation was measured by inserting a thermocouple into the bone approximately 1 mm away from the edge of the hole. The highest temperature was recorded during the drilling / grinding procedure in the six tests.

  After this procedure was completed, the implant was inserted into the hole while the force and torque required for insertion were measured. Implant stability was measured by resonance frequency analysis (RFA) using an instrument from OSSTELL.

  A similar procedure created additional implant holes, but no implant 34 was inserted here. A total of 14 tests were performed on three holes (anterior, middle and posterior) aligned in the medial and lateral rows of the proximal tibia with a 6mm gap between the holes.

  Imaging and characterization of the pressed bone was done using microtomography (micro CT). The high resolution CT slices were aligned along the hole axis with a voxel resolution of 90 μm. Regions of interest were selected and bone mineral content and bone mass ratio were quantified as distance and depth coefficients from the hole edge using GE Microview software.

  Pressed bone imaging and characterization was performed using optical means and ESEM. Bone samples were sectioned along the central axis of the implant hole for microscopic imaging. A low magnification image of the radial edge of the osteotomy site was taken with an optical microscope at a magnification of 20 to 50 times.

To increase the required penetration force and torque, a grooved osteotome grinding technique compared to drilling was shown (Table 1). Also, the force and torque during grinding was related to the diameter of the expansion step, with the highest values (73 N and 18.9 Ncm) occurring during the 5.8 mm step. An implant with a diameter of 3.8 mm was inserted into the drilling hole (maximum torque 15 and 20 Ncm) and one grinding hole (maximum value cannot be measured due to implant failure).

For implants with a diameter of 6.0 mm, drill hole insertion and removal torques were approximately 35 Ncm and 21 Ncm, respectively, and the torque increased significantly during grinding, 80 Ncm and 60 Ncm, respectively (Table 2). When water injection was stopped, bone grinding recorded a higher maximum temperature than drilling. When water injection was started, the grinding only increased the maximum temperature by about 10 ° Fahrenheit (about −12 ° Celsius). There was no significant difference between temperature or implant insertion and removal torque at different grinding speeds. At higher grinding speeds, the maximum penetration force and torque tended to decrease, with 1100 RPM the maximum force was only 27 N and the maximum torque was only 9 Ncm.

The measurement result of the OSSTELL “implant stability index (ISQ)” was about 73 for an implant with a 3.8 mm diameter drilled hole. However, it was not possible to measure with implants with broken ground holes (Table 3). The 6.0 mm implant showed an equivalent ISQ measurement result of approximately 82 for both drilled and ground holes.

  There was no significant difference in the diameter of the holes created by the prior art bar drill or the osteotome 36 of the present invention (either drilling / cutting or grinding mode), but this was not This may be due to the insertion of a 6.0 mm implant in the hole. The osteotome 36 has a tip diameter and top surface diameter (4.8 mm and 5.8 mm, respectively) that is larger than the tip diameter and top surface diameter (4.2 mm and 5.2 mm, respectively) of the prior art bar. In the case of the porcine 02 medial tibial plateau, no implant was inserted into a hole created with a bar drill or grooved osteotome grinding technique prior to micro CT imaging. The diameter of these holes is smaller than the other holes and there is a greater elastic recovery after the osteotome 36 is removed, even though the osteotome 36 has a larger diameter than the prior art bar, Thus, it finally proves to create a smaller diameter hole. For these two tool sizes, the osteotome drilling / cutting procedure appears to create a smaller diameter hole than the prior art bar.

Micro-CT imaging revealed bone compaction around the perimeter of the holes created by grinding, and a relatively increased amount of bone mineral around these holes. On the other hand, this imaging showed a relatively constant amount of bone mineral around the hole created by drilling. For example, FIG. 22 shows the following tools: (A-left) prior art bar drill, (B-center) rotary osteotome 36 rotating in drilling / cutting direction, (C-right) rotary rotating in grinding direction 6 is a micro-CT image showing a transverse slice of a porcine 03 medial tibial plateau with a comparison hole created with osteotome 36. FIG. The highest bone mineral content was observed in the medial, then in the outermost and lowermost part of the central region, and the bone mineral content was varied throughout the tibial plateau. No holes were created in the cortical bone region except for one hole that extended through the full depth of the trabecular region to the bone marrow cavity. Axial projection through a 1 cm volume of bone demonstrated the “halo” of the pressed bone by averaging the non-constant trabecular density. For example, the micro CT images 23A-23D show a tibial intermediate plateau made with a hole in the tibial intermediate plateau of pig 03 (FIG. 23A) made with a prior art bar drill and a rotating osteotome 36 rotating in the grinding direction. FIG. 23 shows a comparative axial slice of the hole (FIG. 23C). In addition, a comparison of average bone mineral content images of a 1 cm volume around the inner hole of pig 02 made with a prior art bar drill (FIG. 23B) and a rotating osteotome 36 rotating in the grinding direction (FIG. 23D). An axial slice view is shown.

  Scanning electron microscope images showed relatively comparable roughness at the surface of the holes created by the prior art bar drill and the osteotome 36 when rotated in the cutting / drilling direction. On the other hand, the grinding osteotome technology created a smooth-looking surface at each stage. Bone grinding results in a layer of granular bone particles that are pressure-molded (ie, autografted) on the long surface of the hole by osteotomy, particularly near the bottom surface of the hole.

  The results of this mechanical validation study demonstrated that the grinding method significantly increased insertion and removal torque, and also created an increase in bone mineral content around the area of the press-molded bone particles and the perimeter of the hole. . Bone grinding techniques produce elastic properties around the ground hole. This grinding technique follows a clinical procedure similar to standard drilling techniques. Even though penetrating force and penetrating torque increased, only a limited temperature rise was seen around the holes when water injection and the “repulsion” method (FIGS. 7 and 8) were used. Although OSSTELL does not suggest any difference between the ISQ of the drilling hole and the ISQ of the grinding hole, all measurements were considered “stable”. The lack of sensitivity of the OSSTELL instrument seems to be due to the fixation stability of a 6.0 mm diameter with an 11 mm long implant.

  The test results showed that the bone grinding technique of the present invention increased the amount of bone mineral around the outer edge of the osteotomy hole. This bone grinding technique increases the primary stability of the implant by generating higher insertion and removal torques for the implant. This bone grinding technique autografts bone along the entire depth of the osteotomy hole, in particular at the bottom of the hole, by reusing the abrasive grains using compression molding. This bone grinding technique has clinical safety similar to prior art bar drills when appropriate rotational speed, penetration speed and water injection are used. This bone grinding technique creates a smaller hole when the osteotome is removed from the hole, due to the restoration of the elastic properties than when using a perforation.

(Another embodiment and application)
FIGS. 24-26 illustrate another embodiment of the present invention, namely an ultrasound osteotome 90 configured to enlarge an osteotomy site without rotation. The ultrasonic osteotome 90 includes a body 92 adjacent to the shank. The body 92 has a tip 94 distal to the shank. The body 92 is generally smooth (ie, has no grooves) and has a conical tapered profile that decreases from a maximum diameter close to the shank to a minimum diameter close to the tip 94. The overall size and dimensions of the body 92 are similar to the body 42 in the previous example. The tip 94 includes a unidirectional grinding structure that may have a rough surface shape. Since the ultrasonic osteotome 90 vibrates at high frequency (by a consumer surgical ultrasonic generator), the tip 94 grinds a small portion of bone in a manner that is not much different from the tip 48 in the previous embodiment. Has an effect. The body 92 is configured to autograft and pressurize the bone after the bone is pulverized ultrasonically by the tip 94 when the body is forcibly advanced to the osteotomy site with high frequency vibration. Further included is an auto-grafting ramp 96. In this example, the autograft ramp 96 is a frustoconical member disposed just below the smooth tapered portion of the body 92. The autograft ramp 96 extends at a first angle that is greater than the taper of the body 92, and the granular bone fragments are compressed toward the enclosure wall of the osteotomy site by a wedge-shaped action.

  27-27B are intended to illustrate to those skilled in the art that the essence of the present invention is not limited solely to dental applications, but for bone pretreatment sites in the human (or animal) body, Suitability may be investigated. The previously stated suggestion is that the spinal and hand / wrist applications are based on the bone stability of the present invention due to the primary stability of the implant, the benefits of autograft, and the inherent similarity to prior art pretreatment techniques. It reveals that it is a major candidate for technology.

  Furthermore, as shown in FIG. 28, the essence of the present invention is not limited to bone as a base material. In fact, the rotating tool 36 of the present invention can be configured to enlarge the hole by grinding in almost any type of spongy material. In this figure, the portion of metallic spongy material 98 may be of a type that is widely used for aerospace, heat resistance, and other important applications. A foam metal comprising holes 100 formed by grinding according to the above method is shown. As a result, the hole 100 is more desirably prepared to receive a screw or other fixation anchor. This is because the inner wall was compressed by the pressure molding displacement and autografting effect of the present invention. Some experiments have also been conducted to form holes in non-sponge-like inorganic materials such as aluminum and plastic plates. Even in these non-sponge-like substances, certain benefits are shown by the hole pretreatment using the present invention, and it is highly expected that the holding power of the screw or anchor is improved.

  The foregoing invention has been described in accordance with the relevant legal standards, and this description is not limiting in nature, but rather is exemplary. Changes and modifications to the disclosed embodiments will be apparent to those skilled in the art and are within the scope of the invention.

Claims (23)

A rotary osteotome configured to continuously rotate in one direction and expand the osteotomy site by grinding;
A shank defining a longitudinal axis of rotation of the rotary osteotome;
A body coupled to the shank, the body having a tip distal to the shank, wherein the body decreases from a maximum diameter adjacent to the shank to a minimum diameter adjacent to the tip. The tip portion includes at least one cutting edge, a plurality of grooves disposed around the main body, and a plurality of lands, each of which is formed between adjacent grooves. Is equipped with a shank,
At least one of the cutting edge and the land is configured to generate an axial reaction force in an opposite direction when continuously rotating in the grinding direction and simultaneously forcibly moving forward to the osteotomy site. The rotary osteotome characterized in that the axial reaction force of the direction is opposite to the direction forcibly moving forward to the osteotomy site.   Each of the grooves has a ground surface and an opposite cut surface, and each of the lands has a land surface that joins the ground surface of the one groove and the cut surface of the adjacent groove. The rotary osteotome according to claim 1, wherein the conical taper has a helical twist that deviates from the grinding direction as the diameter decreases.   The rotary osteotome according to claim 2, wherein each land surface intersects each cut surface along a working edge substantially having no margin.   Each said cutting edge has a substantially flat 1st skirt-like side part, and said 1st skirt-like side part inclines from each said cutting edge at a 1st angle. Item 2. The rotary osteotome according to item 1.   A substantially planar second skirt-like side portion extending away from the first skirt-like side portion at a second angle smaller than the first angle, and a third angle smaller than the second angle. The rotary osteotome according to claim 4, further comprising a substantially planar relief pocket extending away from the second skirt-like side portion at an angle of 5.   The rotary osteotome according to claim 1, wherein the tip portion includes a pair of cutting edges, and the pair of cutting edges are offset from each other so as not to be located in a common plane.   2. The groove of claim 1, wherein each groove has a grinding surface and an opposite cutting surface, the cutting surface defining a rake angle with respect to the longitudinal axis, the rake angle being about zero degrees. Rotating osteotome.   2. The rotary osteotome according to claim 1, wherein the plurality of grooves are evenly arranged in a circumferential direction around the main body, and the plurality of grooves include at least four grooves. A rotary osteotome that is rotated in one direction and configured to expand an osteotomy site by grinding, wherein the rotary osteotome is:
A shank defining a longitudinal axis of rotation;
A body joined to the shank, the body having a tip distal to the shank, the body decreasing from a maximum diameter adjacent to the shank to a minimum diameter adjacent to the tip; A conical tapered property, the tip includes at least one cutting edge, and a body having a plurality of grooves disposed around the body,
The rotary osteotome is configured to rotate continuously in the grinding direction and to perform autologous bone transplantation and pressure molding simultaneously when forcibly advanced toward the osteotomy site.   10. The rotary osteotome according to claim 9, wherein the cutting edge has a substantially flat first skirt-shaped side surface portion, and the first skirt-shaped side surface portion is inclined from the cutting edge. .   A substantially planar second skirt-like side portion extending away from the first skirt-like side portion at a second angle smaller than the first angle; and a third angle smaller than the second angle. The rotary osteotome according to claim 10, further comprising a substantially planar relief pocket extending away from the second skirt-like side surface at an angle.   Each groove has a grinding surface and an opposite cut surface, and further includes a plurality of lands, each land being formed between adjacent grooves, each land having a grinding surface of the one groove, and The rotary osteotome according to claim 9, further comprising a land surface that joins a cut surface of an adjacent groove, and the cut surface defines a rake angle with respect to the longitudinal axis.   13. The rotary osteotome according to claim 12, wherein each land surface intersects each cut surface along a working edge substantially having no margin, and the rake angle is about zero degrees.   14. The rotary osteotome according to claim 13, wherein the working end having substantially no margin has a helical twist that deviates from the grinding direction as the conical taper decreases in diameter.   The rotary osteotome according to claim 9, wherein the tip portion includes a pair of the cutting edges facing each other, and the pair of cutting edges are offset from each other so as not to be located in a common plane.   The rotary groove according to claim 9, wherein the plurality of grooves are uniformly attached in a circumferential direction around the body, the plurality of grooves include at least four grooves, and the plurality of grooves have a helical twist. Osteotome. A rotary hole forming tool configured to be rotated in one direction at a high speed so as to enlarge the hole by grinding and rotated in the opposite direction so as to enlarge the hole by cutting;
A shank having an elongated cylindrical shaft, defining a longitudinal axis of rotation and having a joint for locking a drill motor;
A body coupled to the shank, the body having a tip distal to the shank, wherein the body decreases from a maximum diameter adjacent to the shank to a minimum diameter adjacent to the tip. And the tip includes a pair of cutting edges, each cutting edge having a substantially flat first skirt-like side surface inclined from each cutting edge at a first angle; A substantially planar second skirt side surface extending away from the first skirt side surface portion at a second angle smaller than the first angle, and a third angle smaller than the second angle. A substantially planar relief pocket extending away from the second skirt-like side portion at an angle of
A plurality of grooves are arranged around the main body, the plurality of grooves are equally arranged around the main body in the circumferential direction, the grooves have a helically twisted portion, and each groove has a grinding surface and an opposite cutting surface. Each land is formed between two adjacent grooves, and each land has a land surface that joins the ground surface of the one groove and the cut surface of the adjacent groove. In addition, each land surface intersects each cut surface along a working end having substantially no margin, and the conical tapered shape reduces the diameter of the working end having substantially no margin. With a helical twist that deviates from the grinding direction as
The rotary osteotome is continuously rotated in the grinding direction and is forcibly advanced toward the osteotomy site, and is configured to simultaneously perform bone autograft and pressure molding, and the rotary osteotome The rotary tool further configured to generate an opposite axial reaction force when continuously rotated in the grinding direction and forcibly advanced toward the osteotomy site. An ultrasound osteotome configured to enlarge the osteotomy site,
Shank,
A body coupled to the shank, the body having a tip distal to the shank, the body decreasing from a maximum diameter adjacent to the shank to a minimum diameter adjacent to the tip; A main body having a smooth conical taper shape, the tip including a grinding structure in only one direction, and
The main body is configured such that after the main body is forcibly advanced toward the osteotomy site by high-frequency vibration and the bone is pulverized by ultrasonic waves by the tip, the bone is autografted and pressure-molded. An ultrasonic osteotome characterized in that it includes an autograft lamp.   The ultrasonic osteotome according to claim 18, wherein the autograft lamp is substantially frustoconical. A method for enlarging an osteotomy site by grinding,
Rotating the grooved body continuously in the grinding direction, the body having a conical taper shape that decreases from a tip and a maximum diameter to a minimum diameter close to the tip. Having steps;
Forcing the body forward to the osteotomy site;
Progressively grinding a larger amount of aggregate while advancing the body deeper within the osteotomy site;
The ground aggregate in the osteotomy site is autografted to the receiving bone, and at the same time, the ground aggregate in the osteotomy site is pressed into the receiving bone with the grooved body. Comprising the steps of:   21. The method of claim 20, further comprising generating an axial reaction force that is opposite to a direction that is forced to advance toward the osteotomy site. A method for enlarging an osteotomy site by grinding,
Continuously rotating the grooved body in the grinding direction, the body having a tip and a conical taper shape that decreases from a maximum diameter to a minimum diameter close to the tip. , Steps and
Forcing the rotating body to advance to the osteotomy site;
Progressively grinding a larger amount of aggregate while advancing the body deeper within the osteotomy site;
Generating an axial reaction force opposite to the advancing direction within the osteotomy site.   Autotransplanting the ground aggregate into a receiving bone in the osteotomy site, and press-molding the ground aggregate in the osteotomy site into the receiving bone with the grooved body 26. The method of claim 25, further comprising:

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